The Ethical Standards in Health and Life Sciences Group (ESHLSG) today published a new series of clinical trial transparency principles and facts. This is the first time that leading healthcare professional bodies and senior representatives of the pharmaceutical industry have agreed to a joint approach on this critical issue. This is an important step forward in the on-going move across the entire research community to drive best practice in clinical research reporting.
The ESHLSG Principles document was introduced, at today’s joint British Medical Journal (BMJ) and Association of the British Pharmaceutical Industry (ABPI) conference: Innovation in research methods and dissemination - ensuring best practice.
Sir Richard Thompson, co-chair of the ESHLSG and president of the RCP, commented:
"Clinical trials are critical to ensuring the safety and effectiveness of new medicines and devices. Swift and effective transition from research to new treatments is best achieved by organisations from all sectors coming together to address the significant issues.
"As health professionals treating seriously ill patients on a day-to-day basis, we want to see new developments translated into health benefits as quickly and as safely as possible. Transparency in the results of clinical trials will allow researchers access to more data about how patients respond to new treatments, which can support efforts to see medicines and devices benefit patients sooner.’
Deepak Khanna, co-chair of the ESHLSG and president of the ABPI, said:
"Clinical research is an essential part of the medicine development process, but the results give us far more than proof of safety and efficacy: they are a source of information to all medical researchers. Scientists can examine, question and utilise trial data, and that can only benefit the healthcare community and patients. I’m delighted that so many healthcare leaders are involved in this project – we will be far more effective in finding the right solutions if we work together.
"It is in all of our interests to be transparent, and it is incredibly encouraging to see the collaborations that have brought about this conference and the publication of the Principles document."
Dr Clare Gerada, chair of the Royal College of General Practicioners, said:
"The relationship between healthcare and the pharmaceutical industry can be confusing, for professionals as well as patients, and the lines between the two sides can become blurred. This work will provide much-needed clarity, as well as setting new standards for transparency and best practice that will provide reassurance for those undergoing the trials, patients and the wider public."
Dr Catherine Duggan, director of professional development and support at the Royal Pharmaceutical Society (RPS), said:
"Ensuring trust and transparency between professional, patients, the public and the pharmaceutical Industry is of paramount importance. The RPS is very supportive of this initiative and welcomes this as an essential first step."
Dr Richard Tiner, president of the Faculty of Pharmaceutical Medicine, said:
"The Faculty of Pharmaceutical Medicine welcomes the publication of Clinical Trial Transparency – Principles and Facts and strongly endorses the guidance contained within. The Faculty believes that only through the open sharing of clinical trial data, whatever the outcome of the trial, will patients feel the true benefits of clinical research. Our own Guiding Principles for Pharmaceutical Physicians document (referenced therein) also promotes this philosophy."
The Ethical Standards in Health and Life Sciences Group (ESHLSG) is made up of the following partner organisations:
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